MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM

Model Number	FR8A-RCV-A0,FR8A-SPR-B0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Stimwave quality has investigated the details surrounding a complaint resulting from an infection reported to stimwave on november 26, 2018, by stimwave clinical specialist.Following a successful trial with the freedom spinal cord stimulator (scs) system, the patient had a permanent procedure performed on (b)(6) 2018, in which a freedom-8a receiver stimulator (fr8a-rcv-a0), freedom-8a spare lead (fr8a-spr-b0), and sandshark injectable anchor (sia) system (shrk-all-1k) were implanted in the spinal cord at the s1-l5 level (bilateral transgrade) to treat the patient's bilateral foot pain.There were no complications during the procedure, and the patient was discharged the same day.The implanting clinician met with the patient at a follow-up appointment on (b)(6) 2018, where the patient complained of an upset stomach due to the antibiotics she was taking.It is unknown if the patient continued with the antibiotics, or if the implanting clinician prescribed a different antibiotic.The clinician did not observe any signs of infection at the incision sites at this appointment, and the patient reported no complications with her device, but stated that her menopause was causing her to sweat throughout the night and she would have to change her bandages.The patient returned to the implanting clinician's office on (b)(6) 2018 and (b)(6) 2018 for bandage changes and continued to report good stimulation, but persistent sweating at night.At the (b)(6) 2018 appointment, the implanting clinician noted that the incision sites had some drainage, but did not appear infected or cause any discomfort for the patient.The implanting clinician requested home health services to properly change her bandages and dress the incision sites, but the patient either refused this service, or missed their connection attempts.The patient did not report any issues with the device, or changes in pain relief.On (b)(6) 2018, a second stimwave clinical specialist met with the patient to provide additional transmitting antennas, and reported that the patient's incision sites appeared to be healing, and the patient was continuing to receive therapeutic relief from her pain with the device.The patient returned to the implanting clinician's office on (b)(6) 2018 to have her stitches removed.During this appointment, the implanting clinician did not observe any new signs of infection at the incision sites.At a follow up appointment with the implanting clinician on (b)(6) 2018 for reprogramming and incision site evaluation, the incision sites "was" notably larger and appeared infected compared to the incision sites at the previous appointment.The implanting clinician scheduled an explant of her device the following day because the patient's incision sites were not healing.On (b)(6) 2018, the implanting clinician explanted the patient's device and prescribed antibiotics (name, dose, and duration is unknown).The device was working, and providing therapeutic pain relief up to the date of explant.There were no complications with the explant procedure, and the patient will follow up with the implanting clinician for wound site healing evaluation on a later date (unknown to stimwave).Immediately following notification, stimwave quality and management reviewed the procedure and after care with the clinical specialist present at the procedure.The clinical specialist confirmed that the procedure was performed in a sterile environment, sterile field handling protocols were used, the procedure was completed in accordance with the product instructions for use, and the sterile barriers of all product used were intact prior to implant.No complications arose during the implant procedure.The clinician prescribed antibiotics for the patient to take for infection prevention, but it is not known if the patient complied with antibiotic treatment following the implant.The implanting clinician attempted to prevent infection by requesting home health services to clean and dress the incision sites, but the patient refused this service.To rule out any potential issues with product sterility, stimwave reviewed sterilization records on product from inventory, which confirmed the products from the same lots are sterile out of the package.The raw data from sterilization cycle matched the cycle specification.Stimwave quality, engineering, and manufacturing verified that the correct cycle specification was used for the stimulator lot.The source of the issue was not traced back to compromised product sterility or operating room conditions.While surgical site infection is a known complication of surgery and is listed as a contraindication in the instructions for use, no pathology reports were completed to confirm an infection.The source of the issue was not traced back to compromised product sterility or operating room conditions, and the explantation was due to patient comorbidity, which may have contributed to the incision sites not healing and eventual infection.However it is likely attributed to the patient's noncompliance to post operative care and refusal of additional preventive services.The patient's personal hygiene and home environment are uncontrolled factors that may have contributed to the presentation of the infection.At this time, it is undetermined that the device caused or contributed to the issue.However, it is likely attributed to a lack of compliance to wound care practices at the patient's home environment.The device did not fail to meet performance or safety specifications during the procedure.Stimwave will continue to trend events.The root cause of the complaint is not attributed to device failure, the inability of the device to meet performance or safety specifications, nor nonconformance to physical or functional device specifications.The root cause is likely attributed to the patient's lack of compliance to wound care practices at the patient's home environment, or factors outside the control of stimwave and medical professionals.The stimwave product was not the source of the issue.Corrective action is not required to remedy the root cause of the complaint.The device did not fail to meet performance or safety specifications.Stimwave has confirmed that the product was delivered sterile, and the sterile barriers were not compromised.Infection is a known adverse event for spinal cord stimulation and the freedom scs system, and is detailed in stimwave's risk management file as well as applicable instruction for use and patient-facing labeling.Stimwave was in constant contact with the therapy specialist starting november 26, 2018, regarding the complaint and the root cause investigation.Stimwave confirmed that the product was provided sterile, did not fail to meet performance and safety specifications, and verified that the surgery center had demonstrated compliance with sterilizations standard for implantation procedures for treatment.The source of the issue was not traced back to compromised product sterility or operating room conditions, and the explantation was due to patient comorbidity, which may have contributed to the incision sites not healing and eventual infection.Stimwave has informed all parties that the product was not the source of the issue.In compliance with medical device reporting requirements and responsibilities, stimwave quality and its chief medical officer have determined that this issue is considered reportable as infection can be considered an injury, and medical or surgical intervention was required to preclude permanent impairment or damage.Stimwave has reported this as an adverse event.
Event or Problem Description
Following a successful trial with the freedom spinal cord stimulator (scs) system, the patient had a permanent procedure performed on (b)(6) 2018, in which a freedom-8a receiver stimulator (fr8a-rcv-a0), freedom-8a spare lead (fr8a-spr-b0), and sandshark injectable anchor (sia) system (shrk-all-1k) were implanted in the spinal cord at the s1-l5 level (bilateral transgrade) to treat the patient's bilateral foot pain.There were no complications during the procedure, and the patient was discharged the same day.At a follow up appointment with the implanting clinician on (b)(6) 2018 for reprogramming and incision site evaluation, the incision sites "was" notably larger and appeared infected compared to the incision sites at the previous appointment.The implanting clinician scheduled an explant of her device the following day because the patient's incision sites were not healing.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• MDR Report Key: 8110942
• Report Number: 3010676138-2018-00012
• Device Sequence Number: 18893319
• Product Code: GZB
• UDI-Device Identifier: 00859619004875
• UDI-Public: (01)00859619004875(17)191101(01)00859619004905(17)191201(21)207254-36
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 11/01/2019
• Device Model Number: FR8A-RCV-A0,FR8A-SPR-B0
• Device Catalogue Number: S8R-1A US
• Device Lot Number: SWO171109,SWO171206
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/26/2018
• Device Age: 1 YR
• Event Location: Home
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 11/28/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR